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FDA 510(k)

STAR TEMPORARY WOUND COVER

K-Number: K983753 · 1999-11-18

ApplicantOsteogenics, Inc.
Decision Date1999-11-18
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STAR TEMPORARY WOUND COVER is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics, Inc.. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K983753. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR TEMPORARY WOUND COVER?

STAR TEMPORARY WOUND COVER is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Osteogenics, Inc.. The 510(k) number is K983753.

When did STAR TEMPORARY WOUND COVER receive FDA 510(k) clearance?

STAR TEMPORARY WOUND COVER received FDA 510(k) clearance on 1999-11-18, under 510(k) number K983753.

Who is the listed applicant for STAR TEMPORARY WOUND COVER?

The FDA 510(k) record lists Osteogenics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAR TEMPORARY WOUND COVER?

The FDA product code for STAR TEMPORARY WOUND COVER is FTL.

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Other records listing Osteogenics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061934XTACK964537BONESOURCE HYDROXYAPATITE CEMENT (HAC)K953339BONESOURCE HYDROXYAPATITE CEMENT (HAC)

Related Devices (Code: FTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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